Legislative and Administrative Changes Needed To Improve Regulation of Drug Industry

HRD-83-24: Published: Apr 5, 1983. Publicly Released: Apr 5, 1983.

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Due to recent congressional concern about the significant decrease in the number of regulatory actions taken by the Food and Drug Administration (FDA), GAO reviewed FDA compliance activities to determine whether appropriate and timely regulatory actions are being taken against firms violating the law.

GAO found that, while the number of regulatory actions taken by FDA decreased considerably in fiscal year (FY) 1981, they increased in the category of regulatory letters during FY 1982 because of what may be a one-time intensive effort against the manufacture of "look-alike" drugs. The primary factor influencing the decline of regulatory actions has increased FDA emphasis on voluntary compliance. Other significant factors include: (1) a 24-percent reduction in the number of inspectors; (2) an emphasis on abbreviated inspections; and (3) merit pay contracts which may discourage the submission of proposed regulatory actions because disapproved actions adversely affect performance ratings. GAO believes that, because FDA does not know how well voluntary compliance is working, it should develop a mechanism to measure whether the voluntary approach is resulting in compliance. Finally, GAO concluded that more timely and appropriate regulatory actions could be taken if the number of disapproved recommended actions could be reduced.

Matter for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: From March through June 1987, GAO worked with staff of the Subcommittee on Oversight and Investigation, House Committee on Energy and Commerce, to develop legislative language relating to a number of legislative recommendations, including this recommendation. To date, no bills have been introduced to implement this recommendation.

    Matter: Congress should amend section 304(g) of the Food, Drug and Cosmetic Act by adding drug products to the language which gives FDA the authority to administratively detain medical devices.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA initiated various activities to foster improved field headquarters communications. These include new procedures to speed up case processing and revised procedures for reviewing inspection warrant requests.

    Recommendation: The Secretary of Health and Human Services should require the Commissioner, FDA, to encourage greater coordination and communications among district investigators, district compliance officials, and headquarters officials to better ensure: (1) district and headquarters officials agree on actions to be taken; and (2) documentation to support recommended actions is appropriate.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: FDA issued regulatory procedures manual guidance regarding routine and nonroutine injunction and prosecution cases. This procedure will be periodically assessed and modified as necessary.

    Recommendation: The Secretary of Health and Human Services should require the Commissioner, FDA, to provide additional guidance to the district offices on evidence required to support proposed regulatory actions.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: FDA believes that its current policy is adequate. Cases which demonstrate significant policy issues are distributed with appropriate policy analysis and interpretation.

    Recommendation: The Secretary of Health and Human Services should require the Commissioner, FDA, to develop and distribute to all districts definitive policies on actions to be taken on violations involving medically insignificant drugs and technical violations of good manufacturing practice regulations.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: FDA developed a mechanism which uses data already in the field information system. This mechanism is reassessed periodically.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a mechanism to measure the extent to which voluntary corrective actions result in compliance.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: A revision to the FDA Inspection Operations Manual, section 592, 31(a)(4), dated September 1984, adopted procedures which meet the intent of this recommendation.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to revise the Inspection Operations Manual to require inspectors to: (1) determine the current status of all prior unresolved deficiencies; and (2) discuss the status of these deficiencies in subsequent inspection reports.

    Agency Affected: Department of Health and Human Services

 

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